Although sleep apnea has been recognized as a critical life-endangering problem, there are still a limited number of doctors or dentists trained to treat this disorder and a limited number of treatments. The traditional options for treating obstructive sleep apnea, which is a medical condition where there is a blockage of the airway usually caused by the soft tissue in the rear of the throat, which collapses and closes during sleep, are with the nasal continuous positive air pressure (nCPAP), an oral airway dilator or with surgery. The treatments using positive air pressure and the oral airway dilators (OAD) are not cures, but reversible management tools.
Some of the common design features in the first generation (OADs) airway dilator resulted in minimal success and gave them a negative image in sleep medicine. The current designs of the OADs have increased their successes, and they are now more widely accepted for managing sleep apnea and are far more user-friendly and socially acceptable.
The current CPAPs on the market are expensive, difficult to adjust and largely uncomfortable, and therefore disagreeable to the patient during the diagnosis and fitting process. Further, a percentage of these devices are non-compliant.
Current publications which are not necessarily directly related to sleep apnea but may be considered prior art to the current invention include:
U.S. Pat. No. 1,800,714 granted to Clapp Apr. 14, 1931, which discloses a stepped device for determining the particular bite when artificial dentures are needed, and the device includes a scale intended to measure the angle of a line drawn from the crest of the upper edentulous ridge to the crest of the lower edentulous ridge.
U.S. Pat. No. Re 23,442 granted to George Nov. 20, 1990, teaches the use of an appliance designed to prevent the occlusion of the oro-pharngeal airway, which includes a front beak.
U.S. Pat. No. 4,997,368 granted to Mayer et al Mar. 5, 1991, discloses an oral measuring device for determining the size of the mouth opening and the range of motion to determine the success or nature of the operation performed following facial or oral surgery.
U.S. Pat. No. 5,154,609 granted to George Oct. 15, 1992, discloses an instrument including calibrations and extensions for registration of the dental bite of a patient, and includes as a combination a bite fork.